Trial Outcomes & Findings for Investigating Idiopathic Pulmonary Fibrosis in Greece (NCT NCT03074149)
NCT ID: NCT03074149
Last Updated: 2022-10-05
Results Overview
Number in each category of non-pharmacological treatment (e.g. start of Long-term oxygen therapy (LTOT), new listing for lung transplantation, physiotherapy) for Idiopathic Pulmonary Fibrosis (IPF) by study visit is reported. The categories of non-pharmacological treatment for Idiopathic Pulmonary Fibrosis (IPF) are the following: * No * Yes * Unknown * Missing
Recruitment status
COMPLETED
Target enrollment
301 participants
Primary outcome timeframe
At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.
Results posted on
2022-10-05
Participant Flow
This was a national, multi -center, observational disease and outcomes registry study based on new data from a significant sample size of Greek idiopathic pulmonary fibrosis (IPF) patients.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
205
|
|
Overall Study
COMPLETED
|
64
|
125
|
|
Overall Study
NOT COMPLETED
|
32
|
80
|
Reasons for withdrawal
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Overall Study
Reason unknown
|
22
|
35
|
|
Overall Study
Death
|
10
|
45
|
Baseline Characteristics
Investigating Idiopathic Pulmonary Fibrosis in Greece
Baseline characteristics by cohort
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 Participants
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.4 Years
STANDARD_DEVIATION 7.27 • n=39 Participants
|
70.8 Years
STANDARD_DEVIATION 7.87 • n=41 Participants
|
71.6 Years
STANDARD_DEVIATION 7.75 • n=35 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
55 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=39 Participants
|
168 Participants
n=41 Participants
|
246 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=39 Participants
|
205 Participants
n=41 Participants
|
301 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
Number in each category of non-pharmacological treatment (e.g. start of Long-term oxygen therapy (LTOT), new listing for lung transplantation, physiotherapy) for Idiopathic Pulmonary Fibrosis (IPF) by study visit is reported. The categories of non-pharmacological treatment for Idiopathic Pulmonary Fibrosis (IPF) are the following: * No * Yes * Unknown * Missing
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 Participants
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months · Yes
|
9 Participants
|
27 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline · No
|
83 Participants
|
162 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline · Yes
|
13 Participants
|
43 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months · No
|
70 Participants
|
137 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months · Yes
|
13 Participants
|
37 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months · Unknown
|
3 Participants
|
1 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months · Missing
|
10 Participants
|
30 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months · No
|
67 Participants
|
127 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months · Yes
|
11 Participants
|
35 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months · Unknown
|
2 Participants
|
7 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months · Missing
|
16 Participants
|
36 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months · No
|
66 Participants
|
116 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months · Yes
|
10 Participants
|
38 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months · Unknown
|
0 Participants
|
7 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months · Missing
|
20 Participants
|
44 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months · No
|
61 Participants
|
109 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months · Yes
|
10 Participants
|
29 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months · Unknown
|
2 Participants
|
2 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months · Missing
|
23 Participants
|
65 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months · No
|
55 Participants
|
96 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months · Unknown
|
0 Participants
|
2 Participants
|
|
Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months · Missing
|
32 Participants
|
80 Participants
|
PRIMARY outcome
Timeframe: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported.
Number of patients in each category of physician's clinical assessment of the probable course of IPF by study visit is reported. Physician's clinical rating of the probable course of IPF (stable, slow or rapid progression) was based on available Forced vital capacity (FVC) results, diffusion capacity for carbon monoxide (DLCO) results, physical examination, hospitalizations/events between the visits. The categories of physician's clinical assessment are the following: * Stable disease * Slow progression * Rapid progression * No judgement possible * Missing
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 Participants
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months (since last visit) · Missing
|
32 Participants
|
80 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline (up to 12 months prior to baseline visit) · Stable disease
|
79 Participants
|
158 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline (up to 12 months prior to baseline visit) · Slow progression
|
13 Participants
|
41 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline (up to 12 months prior to baseline visit) · Rapid progression
|
2 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline (up to 12 months prior to baseline visit) · No judgement possible
|
2 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
Baseline (up to 12 months prior to baseline visit) · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months (since last visit) · Stable disease
|
75 Participants
|
156 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months (since last visit) · Slow progression
|
7 Participants
|
16 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months (since last visit) · Rapid progression
|
3 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months (since last visit) · No judgement possible
|
1 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
3 months (since last visit) · Missing
|
10 Participants
|
30 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months (since last visit) · Stable disease
|
71 Participants
|
140 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months (since last visit) · Slow progression
|
4 Participants
|
23 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months (since last visit) · Rapid progression
|
5 Participants
|
6 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months (since last visit) · No judgement possible
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
6 months (since last visit) · Missing
|
16 Participants
|
36 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months (since last visit) · Stable disease
|
64 Participants
|
134 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months (since last visit) · Slow progression
|
10 Participants
|
22 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months (since last visit) · Rapid progression
|
2 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months (since last visit) · No judgement possible
|
0 Participants
|
2 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
12 months (since last visit) · Missing
|
20 Participants
|
44 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months (since last visit) · Stable disease
|
63 Participants
|
113 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months (since last visit) · Slow progression
|
6 Participants
|
21 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months (since last visit) · Rapid progression
|
4 Participants
|
5 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months (since last visit) · No judgement possible
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
18 months (since last visit) · Missing
|
23 Participants
|
66 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months (since last visit) · Stable disease
|
50 Participants
|
100 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months (since last visit) · Slow progression
|
10 Participants
|
21 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months (since last visit) · Rapid progression
|
4 Participants
|
4 Participants
|
|
Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit
24 months (since last visit) · No judgement possible
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported.
Number of physician contacts per patient is reported. For the baseline visit mean and standard deviation of physician contacts with the patient up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of physician contacts with the patient since the last study visit is reported.
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=301 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Physician Contacts Per Patient by Study Visit
Baseline (up to 12 months prior to baseline visit)
|
3.651 physician contacts per patient
Standard Deviation 2.506
|
—
|
|
Number of Physician Contacts Per Patient by Study Visit
3 months (since last visit)
|
0.801 physician contacts per patient
Standard Deviation 1.033
|
—
|
|
Number of Physician Contacts Per Patient by Study Visit
6 months (since last visit)
|
0.676 physician contacts per patient
Standard Deviation 0.832
|
—
|
|
Number of Physician Contacts Per Patient by Study Visit
12 months (since last visit)
|
1.105 physician contacts per patient
Standard Deviation 1.406
|
—
|
|
Number of Physician Contacts Per Patient by Study Visit
18 months (since last visit)
|
0.778 physician contacts per patient
Standard Deviation 0.985
|
—
|
|
Number of Physician Contacts Per Patient by Study Visit
24 months (since last visit)
|
0.553 physician contacts per patient
Standard Deviation 0.842
|
—
|
PRIMARY outcome
Timeframe: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported.
Number of visits in outpatient department by study visit is reported. For the baseline visit mean and standard deviation of visits in outpatient department up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in outpatient department since the last study visit is reported.
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=301 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Visits in Outpatient Department by Study Visit
Baseline (up to 12 months prior to baseline visit)
|
2.844 visits per patient
Standard Deviation 3.042
|
—
|
|
Number of Visits in Outpatient Department by Study Visit
3 months (since last visit)
|
0.545 visits per patient
Standard Deviation 0.899
|
—
|
|
Number of Visits in Outpatient Department by Study Visit
6 months (since last visit)
|
0.502 visits per patient
Standard Deviation 0.852
|
—
|
|
Number of Visits in Outpatient Department by Study Visit
12 months (since last visit)
|
0.856 visits per patient
Standard Deviation 1.358
|
—
|
|
Number of Visits in Outpatient Department by Study Visit
18 months (since last visit)
|
0.664 visits per patient
Standard Deviation 1.217
|
—
|
|
Number of Visits in Outpatient Department by Study Visit
24 months (since last visit)
|
0.489 visits per patient
Standard Deviation 0.939
|
—
|
PRIMARY outcome
Timeframe: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported.
Number of visits in pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in pulmonologists since the last study visit is reported.
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=301 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Visits in Pulmonologists by Study Visit
Baseline (up to 12 months prior to baseline visit)
|
3.027 visits per patient
Standard Deviation 2.209
|
—
|
|
Number of Visits in Pulmonologists by Study Visit
3 months (since last visit)
|
0.654 visits per patient
Standard Deviation 0.839
|
—
|
|
Number of Visits in Pulmonologists by Study Visit
6 months (since last visit)
|
0.624 visits per patient
Standard Deviation 0.777
|
—
|
|
Number of Visits in Pulmonologists by Study Visit
12 months (since last visit)
|
0.928 visits per patient
Standard Deviation 1.171
|
—
|
|
Number of Visits in Pulmonologists by Study Visit
18 months (since last visit)
|
0.698 visits per patient
Standard Deviation 1.05
|
—
|
|
Number of Visits in Pulmonologists by Study Visit
24 months (since last visit)
|
0.479 visits per patient
Standard Deviation 0.749
|
—
|
PRIMARY outcome
Timeframe: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported.
Number of visits in other physicians than the pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in other physicians than the pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in other physicians than the pulmonologists since the last study visit is reported.
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=301 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
Baseline (up to 12 months prior to baseline visit)
|
1.056 visits per patient
Standard Deviation 2.012
|
—
|
|
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
3 months (since last visit)
|
0.34 visits per patient
Standard Deviation 0.626
|
—
|
|
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
6 months (since last visit)
|
0.358 visits per patient
Standard Deviation 0.749
|
—
|
|
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
12 months (since last visit)
|
0.561 visits per patient
Standard Deviation 0.979
|
—
|
|
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
18 months (since last visit)
|
0.588 visits per patient
Standard Deviation 1.098
|
—
|
|
Number of Visits in Other Physicians Than the Pulmonologists by Study Visit
24 months (since last visit)
|
0.505 visits per patient
Standard Deviation 0.831
|
—
|
PRIMARY outcome
Timeframe: At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported.
Number of Idiopathic Pulmonary Fibrosis (IPF) related procedures by study visit is reported. For the baseline visit mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures since the last study visit is reported.
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=301 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
Baseline (up to 12 months prior to baseline visit)
|
2.638 IPF related procedures per patient
Standard Deviation 1.067
|
—
|
|
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
3 months (since last visit)
|
1.216 IPF related procedures per patient
Standard Deviation 1.015
|
—
|
|
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
6 months (since last visit)
|
1.271 IPF related procedures per patient
Standard Deviation 1.026
|
—
|
|
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
12 months (since last visit)
|
1.722 IPF related procedures per patient
Standard Deviation 1.241
|
—
|
|
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
18 months (since last visit)
|
1.613 IPF related procedures per patient
Standard Deviation 1.27
|
—
|
|
Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit
24 months (since last visit)
|
1.569 IPF related procedures per patient
Standard Deviation 1.345
|
—
|
PRIMARY outcome
Timeframe: At baseline up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
Number of patients in each category of hospitalizations by study visit is reported. For the baseline visit number of patients in each category of hospitalizations up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months number of patients in each category of hospitalizations since the last study visit is reported. The categories of hospitalization were: * No * Yes * Unknown * Missing
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 Participants
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
Baseline (up to 12 months prior to baseline visit) · No
|
83 Participants
|
183 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
Baseline (up to 12 months prior to baseline visit) · Yes
|
13 Participants
|
22 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
Baseline (up to 12 months prior to baseline visit) · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
Baseline (up to 12 months prior to baseline visit) · Missing
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
3 months (since last visit) · No
|
85 Participants
|
169 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
3 months (since last visit) · Yes
|
1 Participants
|
5 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
3 months (since last visit) · Unknown
|
0 Participants
|
1 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
3 months (since last visit) · Missing
|
10 Participants
|
30 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
6 months (since last visit) · No
|
80 Participants
|
162 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
6 months (since last visit) · Yes
|
0 Participants
|
7 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
6 months (since last visit) · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
6 months (since last visit) · Missing
|
16 Participants
|
36 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
12 months (since last visit) · No
|
73 Participants
|
152 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
12 months (since last visit) · Yes
|
3 Participants
|
9 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
12 months (since last visit) · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
12 months (since last visit) · Missing
|
20 Participants
|
44 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
18 months (since last visit) · No
|
72 Participants
|
132 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
18 months (since last visit) · Yes
|
1 Participants
|
8 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
18 months (since last visit) · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
18 months (since last visit) · Missing
|
23 Participants
|
65 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
24 months (since last visit) · No
|
62 Participants
|
120 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
24 months (since last visit) · Yes
|
2 Participants
|
5 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
24 months (since last visit) · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Hospitalizations by Study Visit
24 months (since last visit) · Missing
|
32 Participants
|
80 Participants
|
PRIMARY outcome
Timeframe: From signing the informed consent onwards until the end of the study, up to 24 months.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
Number of patients in each category with usage of pirfenidone and nintedanib is reported. The categories for usage of pirfenidone and nintedanib are the following: * Yes * No * Unknown * Missing
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 Participants
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Nintedanib · No
|
41 Participants
|
116 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Pirfenidone · Yes
|
33 Participants
|
87 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Pirfenidone · No
|
54 Participants
|
114 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Pirfenidone · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Pirfenidone · Missing
|
9 Participants
|
4 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Nintedanib · Yes
|
45 Participants
|
81 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Nintedanib · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib
Nintedanib · Missing
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From signing the informed consent onwards until the end of the study, up to 24 months.Population: Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
Concomitant medication was defined as any treatment presented following the Informed Consent Form (ICF) signature. If stop date was missing in the electronic Case Report Form (eCRF), medication was considered as concomitant. The number of patients in each category of the following concomitant medications is reported. The concomitant medications are: * Corticosteroids * N-Acetylcysteine * Azathioprine * Cyclophosphamide * Cyclosporine A * Other immuno-suppressant * Anticoagulants * Gastroesophageal reflux disease (GERD) medication * Phosphodiesterase type 5 (PDE-5) inhibitor * Endothelin receptor antagonist * Non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin * Hormonal contraceptives * Hormone replacement therapy * Anti-vascular endothelial growth factor (VEGF) drugs * Other (other than listed above) The categories for each concomitant medication listed above are the following: * Yes * No * Unknown * Missing
Outcome measures
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 Participants
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 Participants
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Number of Patients in Each Category of Concomitant Medications
Corticosteroids · Yes
|
11 Participants
|
21 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Corticosteroids · No
|
73 Participants
|
175 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Corticosteroids · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Corticosteroids · Missing
|
12 Participants
|
9 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
N-Acetylcysteine · Yes
|
1 Participants
|
3 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
N-Acetylcysteine · No
|
83 Participants
|
194 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
N-Acetylcysteine · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
N-Acetylcysteine · Missing
|
12 Participants
|
8 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Azathioprine · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Azathioprine · No
|
84 Participants
|
197 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Azathioprine · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Azathioprine · Missing
|
12 Participants
|
8 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclophosphamide · Yes
|
0 Participants
|
1 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclophosphamide · No
|
84 Participants
|
195 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclophosphamide · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclophosphamide · Missing
|
12 Participants
|
9 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclosporine A · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclosporine A · No
|
84 Participants
|
195 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclosporine A · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Cyclosporine A · Missing
|
12 Participants
|
10 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other immuno-suppressant · Yes
|
0 Participants
|
4 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other immuno-suppressant · No
|
81 Participants
|
189 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other immuno-suppressant · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other immuno-suppressant · Missing
|
15 Participants
|
12 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anticoagulants · Yes
|
34 Participants
|
67 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anticoagulants · No
|
53 Participants
|
129 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anticoagulants · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anticoagulants · Missing
|
9 Participants
|
9 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
GERD medication · Yes
|
28 Participants
|
84 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
GERD medication · No
|
57 Participants
|
110 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
GERD medication · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
GERD medication · Missing
|
11 Participants
|
11 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
PDE-5 inhibitor · Yes
|
0 Participants
|
5 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
PDE-5 inhibitor · No
|
83 Participants
|
189 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
PDE-5 inhibitor · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
PDE-5 inhibitor · Missing
|
13 Participants
|
11 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Endothelin receptor antagonist · Yes
|
0 Participants
|
2 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Endothelin receptor antagonist · No
|
84 Participants
|
192 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Endothelin receptor antagonist · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Endothelin receptor antagonist · Missing
|
12 Participants
|
11 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
NSAIDs other than aspirin · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
NSAIDs other than aspirin · No
|
84 Participants
|
194 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
NSAIDs other than aspirin · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
NSAIDs other than aspirin · Missing
|
12 Participants
|
11 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormonal contraceptives · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormonal contraceptives · No
|
83 Participants
|
192 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormonal contraceptives · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormonal contraceptives · Missing
|
13 Participants
|
13 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormone replacement therapy · Yes
|
2 Participants
|
2 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormone replacement therapy · No
|
81 Participants
|
188 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormone replacement therapy · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Hormone replacement therapy · Missing
|
13 Participants
|
15 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anti-VEGF drugs · Yes
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anti-VEGF drugs · No
|
83 Participants
|
192 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anti-VEGF drugs · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Anti-VEGF drugs · Missing
|
13 Participants
|
13 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other · Yes
|
85 Participants
|
176 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other · No
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other · Unknown
|
0 Participants
|
0 Participants
|
|
Number of Patients in Each Category of Concomitant Medications
Other · Missing
|
11 Participants
|
29 Participants
|
Adverse Events
IPF Patients With Less Than 6 Months Diagnosis
Serious events: 7 serious events
Other events: 10 other events
Deaths: 10 deaths
IPF Patients With Equal or More Than 6 Months Diagnosis
Serious events: 22 serious events
Other events: 21 other events
Deaths: 45 deaths
Serious adverse events
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 participants at risk
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 participants at risk
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
1.5%
3/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.00%
0/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
2.0%
4/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
General disorders
Death
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Infections and infestations
Gastroenteritis
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.00%
0/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
1.5%
3/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Injury, poisoning and procedural complications
Transplantation complication
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.00%
0/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Investigations
Weight decreased
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Nervous system disorders
Ischaemic stroke
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.00%
0/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.00%
0/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
1.0%
1/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
4.4%
9/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
0.49%
1/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
1.5%
3/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
Other adverse events
| Measure |
IPF Patients With Less Than 6 Months Diagnosis
n=96 participants at risk
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
IPF Patients With Equal or More Than 6 Months Diagnosis
n=205 participants at risk
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.4%
10/96 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
10.2%
21/205 • From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER